Nov 2 to Nov 8, 2026

MODERN MEDICAL SUPPLIES LLC

CDRH · Devices · Nevada, United States

LGM Pharma Solutions, LLC

CDER · Drugs · California, United States

USV Private Limited

CDER · Drugs · India

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Inspections classified Official Action Indicated 3

BioTissue Holdings IncOAI

OAI · Biologics · Human Cellular, Tissue, and Gene Therapies · Florida, United States

FDA firm profile · Inspection history on Arca

MODERN MEDICAL SUPPLIES LLCOAI

OAI · Devices · Postmarket Assurance: Devices · Nevada, United States · 483 citations posted

FDA firm profile · Inspection history on Arca

Emerge Technologies IncOAI

OAI · Devices · Compliance: Devices · Texas, United States · 483 citations posted

FDA firm profile · Inspection history on Arca

Recalls 31

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Greenwich RxClass I

Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only…

Class I · Drug · Microbial Contamination of Sterile Products

Par Health USA, LLCClass I

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA… (and 1 more product)

Class I · Drug · Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.

Philips Ultrasound, LLCClass I

Philips Lumify Diagnostic Ultrasound System

Class I · Device · Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital…

Ventec Life Systems, Inc.Class I

VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support. (and 11 more products)

Class I · Device · Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Abbott

Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5…

Class II · Device · Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).

Ascend Laboratories, LLC

Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed…

Class II · Drug · Out of specification due to dissolution.

AVID Medical, Inc.

Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30. (and 1 more product)

Class II · Device · A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.

AvKARE

Amitriptyline Hydrochloride, Tablets, USP, 10 mg, 5 x 10 Unit dose cards in paper cartons, Rx only, Manufactured for AvKARE, Pulaski, TN…

Class II · Drug · Failed dissolution specifications.

Axonics, Inc.

PNE Lead Implant Kit REF: 1701

Class II · Device · Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

B Braun Medical Inc

B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.

Class II · Device · Potential for leakage and backflow at the Safsite valve.

Beckman Coulter, Inc.

ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846… (and 1 more product)

Class II · Device · Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of…

Boston Scientific Cork, Ltd.

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290 (and 40 more products)

Class II · Device · The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves…

CooperVision, Inc.

Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables…

Class II · Device · The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the…

Greiner Bio-One North America, Inc.

Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood…

Class II · Device · Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++)…

Hikma Pharmaceuticals USA INC.

Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights…

Class II · Drug · Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.

Life Technologies Holdings Pte Ltd

Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer

Class II · Device · DNA or RNA sequencing system software has vulnerabilities.

Medline Industries, LP

MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU… (and 12 more products)

Class II · Device · Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Medtronic MiniMed, Inc.

Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version…

Class II · Device · A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose…

Medtronic MiniMed, Inc.

CareLink Clinic, REF: MMT-7350

Class II · Device · CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs)…

Medtronic Navigation, Inc.

Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly (and 3 more products)

Class II · Device · Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

Medtronic Neuromodulation

InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030 (and 1 more product)

Class II · Device · Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for…

Pfizer

Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017… (and 1 more product)

Class II · Drug · Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.

Philips North America

Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;

Class II · Device · Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central…

PRITAM INTERNATIONAL PRIVATE LIMITED

Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz… (and 16 more products)

Class II · Drug · CGMP Deviations.

restor3d Inc.

Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description…

Class II · Device · Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

Right Value Drug Stores LLC

Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-1) and b) 30 m vials ( NDC 73271-1226-2) This Is A Compounded…

Class II · Drug · Lack of sterility assurance.

Shenzhen Techdow Pharmaceutical Co., Ltd.

Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome…

Class II · Drug · Lack of Assurance of Sterility

Solstice Corporation

Xact mole marker for mammography Model/Catalog Number: M15RM

Class II · Device · The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.

STRIDES PHARMA INC

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed…

Class II · Drug · Failed dissolution specifications

TECHNO-PATH MANUFACTURING LTD.

Techno-Path Multichem AE Unassayed Level 2 REF: AE622X (and 2 more products)

Class II · Device · A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the…

Think Surgical, Inc.

Think Surgical Square Driver REF: 109126

Class II · Device · Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.

New guidance documents 2

Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus: Guidance for Industry

Final · CBER

Read at FDA

Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products

Final · CBER

Read at FDA

Federal Register: rules, proposed rules and notices 6

Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion

Final rule · effective 2026-11-06

Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Final rule · effective 2026-11-05

Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment

Final rule · effective 2026-11-05

Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use

Final rule · effective 2026-11-05

Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability

Notice

Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability

Notice